生達四箭齊發 外銷要占50% 2015-08-24 04:53:05 經濟日報 記者黃文奇／台北報導生達製藥銷售四箭，美日台陸齊發。生達專攻美國的糖尿病用藥近期取得藥證，預計第4季在美上市，生達總經理范滋庭表示，未來會持續國際化並強化研發能量，加速推出新藥品項，聚焦中國、美國及日本三大市場，希望五年內達到外銷占比五成的目標。生達今年業績看好，范滋庭表示，下半年營運表現將優於上半年；而明年國內外市場發酵，獲利將齊揚。法人估，今年在新產品上市貢獻下，每股稅後純益（EPS）有機會挑戰2.5元，再創歷史新高。范滋庭表示，生達目前有挑戰第四類學名藥（Paragraph IV）的產品，包括抗多發性硬化症、降高血脂藥，也有機會在明年中以後上市，搶食近15億美元的市場大餅。中國市場方面，生達目前藥證申請也將加快腳步，其中，糖尿病藥可望在今年底、明年初取得，血栓也力拚明年上半年進入市場銷售。范滋庭表示，目前外銷營收占比約二成，以東南亞、中國為主，不過，受到健保藥價調降影響，生達上半年營收15.91億元，較去年同期小幅下滑，毛利率維持在四成以上，達46.48%，稅後純益約1.77億元，年減12.5%，每股稅後純益（EPS）為0.99元。不過，下半年在匯兌利益挹注與公司營運大翻轉下，生達營運可望繼續衝高。其中，范滋庭表示，美國首張藥證到手，打開生達銷美大門，意義重大。其中，美國市場已送審五項產品，降血糖的糖尿病用藥申請時間已六年，近期終於取得上市許可，而該產品又屬於基礎用藥，將透過美國經銷商銷售，將貢獻公司營運。中國市場方面，生達迄今已送件六項產品，今年在該國大力整頓藥品審查機制下，今年取證機會大增。另外，生達與日本DIA製藥合作設立的大陸泰州水性貼布工廠，目前主要生產代工及自創品牌的退熱貼為主，目前年產能2,000萬片，訂單超載，第4季有機會達單月損平，明年將會開始賺錢。台灣方面，代理日本大日本住友製藥在的精神科新藥LATUDA，美國銷售規模已經逾1億美元，近期已完成臨床，有機會在第4季取得藥證，明年上半年申請健保藥價。
Repaglinide is an antidiabetic drug in the class of medications known as meglitinides, and was invented in 1983. It is sold by Novo Nordisk under the name of Prandin in the U.S., GlucoNorm in Canada, Surepost in Japan, Repaglinide in Egypt by EIPICO, and NovoNorm elsewhere. In Japan it is produced by Dainippon Sumitomo Pharma.
A study funded by Novo Nordisk, the U.S. distributor for Repaglinide, compared their product with Nateglinide in "A randomized, parallel-group, open-label, multicenter 16-week clinical trial". They concluded that the two were similar, but "repaglinide monotherapy was significantly more effective than nateglinide monotherapy in reducing HbA1c and FPG values after 16 weeks of therapy." However, 7 percent of the Repaglinide patients "had minor hypoglycemic episodes (blood glucose <50 mg/dl) versus 0 patients for nateglinide"; this difference was not statistically significant. They also cited a 1-year study that concluded that "repaglinide had similar efficacy to glyburide."
Mechanism of Action Repaglinide lowers blood glucose by stimulating the release of insulin from the pancreas. It achieves this by closing ATP-dependent potassium channels in the membrane of the beta cells. This depolarizes the beta cells, opening the cells' calcium channels, and the resulting calcium influx induces insulin secretion.
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